The comparison of effect vaginal herbal cream with placebo in fibroma treatment, Random, Clinical triple blind trial , Women in fertility age (18-45 years old) having fibroma (receiving embryo vaginal cream) and control group (receiving placebo vaginal cream) as follow:
- The intervening group (45 ones) who shall receive embryo vaginal cream from the first day of menstruation for two periods; 3 applicators each night
- Placebo group (45 ones) who shall receive the placebo vaginal cream from first day of menstruation for two periods; 3 applicators each night.
Then effect of embryo vaginal cream on dimensions of uterine fibroma, amount of blooding, and life quality of women will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042217388N1
Registration date:2015-08-15, 1394/05/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-08-15, 1394/05/24
Registrant information
Name
Sousan Houshmandi
Name of organization / entity
Ardebil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 2006
Email address
s.houshmandi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of plant Royan vaginal cream for the treatment of myoma with placebo
Public title
Effect of plant of Royan vaginal cream for the treatment of myoma with placebo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : All women of childbearing age (45 to 18) with at least one Fybrm to1 cm or larger, which is confirmed by ultrasound. Have a negative pregnancy test.
Exclusion criteria : 1. Patients who have had hormone therapy 6 months before the treatment. 2. Patients who have had surgeries before, such as: Myomectomy. 3. Requires immediate surgical. 4. Pregnancy during the treatment 5.Abnormal Pap-Asmyr or severe anemia (8/0 )
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences, Daneshgah St, Ardabil, Iran
City
Ardabil
Postal code
56189-53141
Approval date
2014-04-14, 1393/01/25
Ethics committee reference number
43/525
Health conditions studied
1
Description of health condition studied
Leiomyoma
ICD-10 code
D25
ICD-10 code description
Leiomyoma of uterus
Primary outcomes
1
Description
Reduction in bleeding volume of Myoma
Timepoint
Before and after treatment
Method of measurement
Submit in Higam table
Secondary outcomes
1
Description
The pain of Myoma
Timepoint
Before and after intervention
Method of measurement
VAS measurement
2
Description
Size of the Myoma
Timepoint
Before and after intervention
Method of measurement
Sonography
3
Description
Life style
Timepoint
Before and after intervention
Method of measurement
Questionnaire Code SF36
Intervention groups
1
Description
Intervention: From the first day of menstruation, using of Royan vaginal cream full 3 applicator per night for 2 periods.
Category
Treatment - Drugs
2
Description
Control: From the first day of menstruation, using of Placebo vaginal cream full 3 applicator per night for 2 periods.